Recently, the first prescription of Mindray®, Huadong Medicine's first precision-targeted EGFR exon 21 (L858R) innovative drug, was successfully issued at Shantou Central Hospital. This marks the official commercialization of Mindray® in China, propelling the treatment of non-small cell lung cancer (NSCLC) in my country into a new era of precision-targeted therapy and bringing new hope for survival to patients with locally advanced or metastatic NSCLC suffering from EGFR exon 21 (L858R) substitution mutations!

Lung cancer is the leading cause of cancer-related morbidity and mortality worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of primary lung cancers. In my country, about 70% of NSCLC patients are diagnosed at an advanced stage, resulting in a low five-year survival rate. EGFR exon 21 (L858R) mutation is the major subtype of EGFR mutations, accounting for 35%-41%. Patients with exon 21 (L858R) mutations exhibit more specific clinical characteristics: older age, a higher proportion of females, a significantly increased probability of lymph node metastasis and coexisting mutations, and stronger invasiveness of cancer cells. This leads to faster disease progression and worse prognosis in patients with exon 21 (L858R) mutations, further exacerbating the survival challenges in advanced stages. Currently, EGFR-TKIs on the market are less effective in patients with exon 21 (L858R) mutations than in patients with exon 19 deletion mutations. Therefore, precise targeted therapy against exon 21 (L858R) mutations has become a core direction for improving patient survival outcomes and a crucial gap to be filled in the field of precision lung cancer treatment. The launch of the first formulation of mefanilinib maleate (Mindray®) has broken this treatment impasse and brought new hope to patients.
Results from a multicenter, randomized, controlled phase III study of mefanirtinib maleate showed that in patients with exon 21 (L858R) mutations, the mefanirtinib group had a significant benefit in median progression-free survival (PFS) compared to the gefitinib group: median PFS was 13.73 months (8.28 months in the gefitinib group, HR=0.55, P<0.001). Median overall survival (mOS) data were not yet mature, but mefanirtinib showed a trend toward benefit, with a median OS of 35.88 months in the mefanirtinib group (29.08 months in the gefitinib group, HR=0.76, P=0.2356). The 30-month OS rate was 56.6% in the mefanirtinib group, higher than 43.7% in the gefitinib group.
In addition to its significant efficacy, mefanertinib maleate also demonstrates excellent safety profile. Mefanertinib is well-tolerated, with only 5.8% of patients requiring dose reduction and a permanent discontinuation rate of only 4%. Grade ≥3 adverse reactions are primarily diarrhea and rash, which can be effectively controlled through routine interventions, providing patients with a better treatment experience and quality of life.
Currently, mefanilinib maleate has received a Class I recommendation in the CSCO Non-Small Cell Lung Cancer Treatment Guidelines (2026) and a Class I recommendation in the Chinese Guidelines for the Treatment of Stage IV Primary Lung Cancer (2026 Edition), and is used as a first-line treatment for patients with advanced NSCLC due to EGFR L858R substitution mutations.
In the future, the company will actively leverage its commercial advantages accumulated in the oncology field, fully promote the marketing of Mindray®, and continue to deepen its involvement in the oncology field, constantly enriching its innovative R&D pipeline to bring more high-quality products with clinical benefits to patients.

https://bydrug.pharmcube.com/news/detail/aa957a0d626b9eeb78c0f0b45f2ba62e